Core Viewpoint - PDS Biotechnology Corporation is set to report its financial results for Q1 2025 and provide updates on its clinical programs during a conference call on May 14, 2025 [1][2]. Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on enhancing the immune system's ability to target and eliminate cancers [3]. - The company has initiated a pivotal clinical trial for its lead program, which targets advanced HPV16-positive head and neck squamous cell cancers [3]. - The lead investigational targeted immunotherapy, Versamune HPV, is being developed in combination with a standard immune checkpoint inhibitor and in a triple combination with PDS01ADC, an IL-12 fused antibody drug conjugate [3].

PRINCETON, N.J., April 23, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today announced that three abstracts on Versamune® HPV (PDS0101) have been accepted for presentation at the 2025 American Society of Clinical Oncology (“ASCO”) Annual Meeting, taking place May 30-June 3, 2025, in Chicago, Illinois. Details of the presentation are as follow ...

Core Insights - PDS Biotechnology Corporation announced that preclinical immune response data for a novel Infectimune-based flu vaccine will be presented at the American Association of Immunologists' IMMUNOLOGY2025™ Annual Meeting [1] - The presentation will focus on broadly protective immunity against influenza and opportunities for universal influenza vaccines [2] - PDS Biotech is advancing its lead program in advanced HPV16-positive head and neck squamous cell cancers through a pivotal clinical trial [3] Presentation Details - Title of the presentation: Broadly Protective Immunity against Influenza and Opportunities for Universal Influenza Vaccines [2] - Session Type: Guest Symposium at the International Society of Influenza and Other Respiratory Viruses (ISIRIV) Symposium [2] - Date and Time: May 4, 2025, from 8:30 to 10:30 a.m. HST [2] - Presenter: Andrea Sant, Ph.D., Professor of Microbiology and Immunology at the University of Rochester Medical Center [2] Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on transforming immune responses to target and kill cancers [3] - The company is developing its lead investigational targeted immunotherapy, Versamune HPV, in combination with standard-of-care immune checkpoint inhibitors [3] - PDS Biotech is also exploring a triple combination therapy that includes PDS01ADC, an IL-12 fused antibody drug conjugate, along with standard-of-care immune checkpoint inhibitors [3]

Core Insights - PDS Biotechnology Corporation announced that an abstract on its IL-12 fused antibody drug conjugate, PDS01ADC, has been accepted for presentation at the AACR Annual Meeting 2025 [1][2] - The presentation will focus on alterations in peripheral T stem-like memory cells in patients with advanced solid tumors treated with tumor-targeting IL-12 therapy [2] Company Overview - PDS Biotechnology is a late-stage immunotherapy company aiming to transform immune system responses to cancer [1][2] - The company is advancing its lead program in advanced HPV16-positive head and neck squamous cell cancers through a pivotal clinical trial [2] - PDS Biotech's lead investigational targeted immunotherapy, Versamune® HPV, is being developed in combination with a standard immune checkpoint inhibitor and in a triple combination including PDS01ADC [2]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________to ________ Commission file number 001-37568 PDS Biotechnology Corporation (Exact name of registrant as specified in its charter) Delaware 26-4231384 (State or other juri ...

Financial Data and Key Metrics Changes - The net loss for the year ended December 31, 2024, was approximately $37.6 million or $1.03 per basic and diluted share, compared to a net loss of $42.9 million or $1.39 per basic and diluted share for the prior year [21] - Research and development expenses for 2024 were $22.6 million, down from $27.8 million in 2023, primarily due to decreases in clinical costs, personnel costs, and professional fees [22] - General and administrative expenses for 2024 were $13.8 million, compared to $15.3 million in 2023, reflecting a decrease in professional fees and facilities costs [23] - Total operating expenses for 2024 were $36.3 million, compared to $43 million in 2023 [23] - The company's cash balance as of December 31, 2024, was $41.7 million, not including the direct offering concluded in February 2025 [25] Business Line Data and Key Metrics Changes - The VERSATILE-003 Phase 3 clinical trial of Versamune HPV + pembrolizumab has been initiated, targeting HPV16-positive head and neck cancer, a growing population in need of targeted therapies [8][10] - The trial design includes approximately 350 patients, with a primary endpoint of median overall survival [10][12] - The VERSATILE-002 Phase 2 study showed median overall survival of 30 months, with an objective response rate improvement from 26% to 36% [12][13] Market Data and Key Metrics Changes - HPV-16 positive head and neck cancer is projected to become the most prevalent type of head and neck cancer in the U.S. and Europe by the mid-2030s [9] - The best-published median overall survival for pembrolizumab is 17.9 months, indicating the potential competitive advantage of the Versamune HPV combination [13] Company Strategy and Development Direction - The company aims to be the first to market with an HPV-targeted immunotherapy for head and neck cancer, leveraging strong clinical data from the VERSATILE-002 study [16][84] - The focus remains on progressing the VERSATILE-003 trial while collaborating with the National Cancer Institute on other programs [17][60] - The company plans to raise necessary capital in a stepwise manner as it progresses with the Phase 3 trial, balancing funding needs against shareholder dilution [34][35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of the Versamune HPV combination to improve patient outcomes and enhance standard-of-care [10][16] - The current funding environment is challenging, but the company successfully raised $11 million recently [33] - Management is optimistic about rapid enrollment in the VERSATILE-003 trial due to the familiarity of sites from the Phase 2 trial [30][53] Other Important Information - The company announced FDA clearance for the Investigational New Drug application for the combination of Versamune MUC1 and PDS01ADC to treat metastatic colorectal cancer [16] - The trial design for VERSATILE-003 includes two interim data readouts, allowing for early discussions with the FDA regarding potential accelerated approval [46][47] Q&A Session Summary Question: Enrollment trajectory for Versamune-003 and projected timelines - Management indicated that most sites from the Phase 2 trial are re-engaged, which should expedite enrollment [30] Question: Current funding environment for studies - The company acknowledged the challenging funding environment but expressed satisfaction with recent fundraising efforts [33] Question: Rationale for the reduced patient sample size in VERSATILE-003 - The reduction from over 400 to 350 patients was based on observed durability of responses and retained statistical power [44] Question: Timeline for MUC1 candidate and TARP program - The MUC1 trial is led by the National Cancer Institute, and timelines will depend on their progress [75] - No guidance has been provided for the TARP program at this time [79]

Financial Data and Key Metrics Changes - The net loss for the year ended December 31, 2024, was approximately $37.6 million or $1.03 per basic and diluted share, compared to a net loss of $42.9 million or $1.39 per basic and diluted share for the prior year [21] - Research and development expenses for 2024 were $22.6 million, down from $27.8 million in 2023, primarily due to decreases in clinical costs, personnel costs, and professional fees [22] - General and administrative expenses for 2024 were $13.8 million, compared to $15.3 million in 2023, reflecting a decrease in professional fees and facilities costs [23] - Total operating expenses for 2024 were $36.3 million, compared to $43 million in 2023 [23] - The company's cash balance as of December 31, 2024, was $41.7 million, not including the direct offering concluded in February 2025 [25] Business Line Data and Key Metrics Changes - The VERSATILE-003 Phase 3 clinical trial of Versamune HPV + pembrolizumab has been initiated, targeting HPV16-positive head and neck cancer, a growing population in need of targeted therapies [8][10] - The trial design includes approximately 350 patients, with a primary endpoint of median overall survival [10][12] - The VERSATILE-002 Phase 2 study showed median overall survival at 30 months, with an objective response rate improvement from 26% to 36% [12][13] Market Data and Key Metrics Changes - HPV-16 positive head and neck cancer is projected to become the most prevalent type of head and neck cancer in the U.S. and Europe by the mid-2030s [9] - The best-published median overall survival for pembrolizumab is 17.9 months, while the disease control rate improved from 70% to 77% in the VERSATILE-002 study [13][14] Company Strategy and Development Direction - The company aims to be the first to market an HPV-targeted immunotherapy for head and neck cancer, leveraging the promising results from the VERSATILE-002 study [16][84] - The company is focusing on progressing the VERSATILE-003 trial while maintaining strong relationships with the National Cancer Institute for other clinical trials [17][56] - Future plans include exploring non-dilutive funding options and potential partnerships to support pipeline development [35][38] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenging funding environment but expressed confidence in their ability to raise necessary capital in a stepwise manner as the Phase 3 trial progresses [34][35] - The company is optimistic about the potential for accelerated approval discussions with the FDA based on interim data readouts from the VERSATILE-003 trial [47][49] - Management emphasized the importance of rapid patient enrollment in the trial, aided by the familiarity of sites involved in the previous Phase 2 study [51][53] Other Important Information - The company announced FDA clearance for the Investigational New Drug application for the combination of Versamune MUC1 and PDS01ADC to treat metastatic colorectal cancer [16] - The company is also exploring the potential of a triple combination therapy involving IL-12, pending the success of the doublet therapy [61][70] Q&A Session Summary Question: Enrollment trajectory for Versamune-003 and projected timelines - Management indicated that most sites from the Phase 2 trial are re-engaged, which should expedite enrollment [29][30] Question: Current funding environment for studies - Management acknowledged the challenging funding environment but expressed satisfaction with recent fundraising efforts [33][34] Question: Rationale for the reduced patient sample size in VERSATILE-003 - The trial size was reduced from over 400 to 350 patients based on improved confidence in clinical outcomes from the Phase 2 study [44] Question: Timeline for MUC1 candidate and TARP program - The MUC1 trial is led by the National Cancer Institute, and timelines will depend on their progress [75][79]

Financial Performance - For the year ended December 31, 2024, the net loss was approximately $37.6 million, or $1.03 per basic and diluted share, a decrease from a net loss of $42.9 million, or $1.39 per share in 2023[5] - The accumulated deficit as of December 31, 2024, was $(182.1) million, compared to $(144.5) million in 2023[19] Expenses - Research and development expenses for 2024 were $22.6 million, down from $27.8 million in 2023, primarily due to a $4.1 million decrease in clinical costs[6] - General and administrative expenses decreased to $13.8 million in 2024 from $15.3 million in 2023, reflecting a reduction in professional fees and facilities costs[7] - Total operating expenses for 2024 were $36.3 million, compared to $43.0 million in 2023, indicating a significant reduction in overall costs[7] - The company reported a net interest expense of $2.2 million for 2024, an increase from $1.3 million in 2023 due to higher debt interest[8] Cash Position - The cash balance as of December 31, 2024, was $41.7 million, down from $56.6 million in 2023[11][19] Clinical Trials and Designations - The company initiated the VERSATILE-003 Phase 3 clinical trial for Versamune® HPV in HPV16-positive head and neck cancer, with approximately 350 patients expected to be enrolled[4] - The FDA granted Fast Track designation for the combination of Versamune® HPV and pembrolizumab in recurrent/metastatic head and neck squamous cell carcinoma[4] Fundraising Activities - In March 2025, the company announced an up to $22 million registered direct offering, with $11 million in upfront gross proceeds[10]

Initiated VERSATILE-003 Phase 3 Clinical Trial Evaluating Versamune® HPV in HPV16-Positive Head and Neck Cancer Conference call and webcast today at 8:00 a.m. Eastern Time PRINCETON, N.J., March 27, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today provided a clinical programs update and reported financial results for the full year ended Dece ...

Core Insights - PDS Biotechnology Corporation is a late-stage immunotherapy company focused on enhancing the immune system's ability to target and eliminate cancers [3] - The company will present at the 2025 Cancer Advocacy Group of Louisiana NeauxCancer Conference, highlighting its advancements in cancer treatment [1][2] Company Overview - PDS Biotechnology is developing its lead investigational targeted immunotherapy, Versamune® HPV, in pivotal clinical trials for advanced HPV16-positive head and neck squamous cell cancers [3] - The therapy is being tested in combination with a standard immune checkpoint inhibitor and in a triple combination with PDS01ADC, an IL-12 fused antibody drug conjugate [3] Event Details - The presentation at the 2025 CAGLA NeauxCancer Conference is scheduled for March 28, 2025, at 11:00 AM CT, focusing on innovative cancer treatment approaches [2]